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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Advancing therapy in suboptimally controlled basal insulin–treated type 2 diabetes: Clinical outcomes with iglarlixi versus premix biasp 30 in the solimix randomized controlled trial
Diabetes Care, Volume 44, No. 10, Year 2021
Notification
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Description
OBJECTIVE: To directly compare the efficacy and safety of a fixed-ratio combination, of insulin glargine 100 units/mL and the glucagon-like peptide 1 receptor agonist lixisenatide (iGlar- Lixi), with those of a premix insulin analog, biphasic aspart insulin 30 (30% insulin aspart and 70% insulin aspart protamine) (BIAsp 30) as treatment advancement in type 2 diabetes suboptimally controlled on basal insulin plus oral antihyperglycemic drugs (OADs). RESEARCH DESIGN AND METHODS: In SoliMix, a 26-week, open-label, multicenter study, adults with suboptimally controlled basal insulin–treated type 2 diabetes (HbA1c ‡7.5% and ©10%) were randomized to once-daily iGlarLixi or twice-daily BIAsp 30. Primary efficacy end points were noninferiority in HbA1c reduction (margin 0.3%) or superiority in body weight change for iGlarLixi versus BIAsp 30. RESULTS: Both primary efficacy end points were met: After 26 weeks, baseline HbA1c (8.6%) was reduced by 1.3% with iGlarLixi and 1.1% with BIAsp 30, meeting noninferiority (least squares [LS] mean difference -0.2% [97.5% CI -0.4, -0.1]; P < 0.001). iGlarLixi was also superior to BIAsp 30 for body weight change (LS mean difference -1.9 kg [95% CI -2.3, -1.4]) and percentage of participants achieving HbA1c <7% without weight gain and HbA1c <7% without weight gain and without hypoglycemia (all P < 0.001). iGlarLixi was also superior versus BIAsp 30 for HbA1c reduction (P < 0.001). Incidence and rates of American Diabetes Association level 1 and 2 hypoglycemia were lower with iGlarLixi versus BIAsp 30. CONCLUSIONS: Once-daily iGlarLixi provided better glycemic control with weight benefit and less hypoglycemia than twice-daily premix BIAsp 30. iGlarLixi is a more efficacious, simpler, and well-tolerated alternative to premix BIAsp 30 in suboptimally controlled type 2 diabetes requiring treatment beyond basal insulin plus OAD therapy.
Available Materials
https://efashare.b-cdn.net/share/pmc/articles/PMC8740944/bin/dc21-0393_Video_1.mp4
Authors & Co-Authors
Rosenstock, Julio
United States, Dallas
Dallas Diabetes Research Center at Medical City
Emral, Rifat
Turkey, Ankara
Ankara Üniversitesi
Sauque-Reyna, Leobardo
Mexico, Cuernavaca
Instituto de Diabetes Obesidad y Nutrición S.c.
Mohan, Viswanathan Krishna
India, Chennai
Madras Diabetes Research Foundation
Trescolí, Carlos
Spain, Alzira
Hospital de la Ribera
Al-Sifri, Saud N.
Saudi Arabia, Taif
Al Hada Armed Forces Hospital
Lalić, Nebojša Malić
Serbia, Belgrade
University of Belgrade
Alvarez, Agustina
Unknown Affiliation
Picard, Pascaline
France, Levallois-perret
Ividata Stats
Bonnemaire, Mireille
France, Gentilly
Sanofi S.a.
Demil, Nacima
France, Gentilly
Sanofi S.a.
McCrimmon, Rory J.
United Kingdom, Dundee
University of Dundee School of Medicine
Statistics
Citations: 30
Authors: 12
Affiliations: 10
Identifiers
Doi:
10.2337/dc21-0393
ISSN:
01495992
e-ISSN:
19355548
Research Areas
Health System And Policy
Noncommunicable Diseases
Study Design
Cohort Study
Study Approach
Quantitative